The Effect of Virtual Reality Glasses Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'
NCT ID: NCT05655052
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
37 participants
INTERVENTIONAL
2022-11-15
2023-06-30
Brief Summary
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Detailed Description
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In addition, it has been reported in the literature that women perceive pain during IUD application. In these studies, pain; especially used in the stages of IUD application; It is reported that it is detected during tenaculum insertion, measurement with a hysterometer, and finally during IUD insertion. For this reason, there is a need for applications to reduce the pain associated with the IUD application, which is the modern FP method of women. Again, it is assumed that women will experience anxiety before the IUD application as in other medical procedures . It is seen in the literature that there are studies to alleviate the perceived pain in IUD application . In addition, it is expected that the applications made to women for the symptoms such as pain and anxiety related to the applications in the field of health will increase their satisfaction . In this context, there are studies in the literature showing that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures, reducing the perception of pain and reducing the level of anxiety. . Although virtual reality glasses are a technological device, they have been widely used in the medical field in hospitals. Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The applications to be made with this device are within the framework of midwifery care applications and are not a treatment method, mediator or treatment option for any disease and do not have any harmful effects. Again, the cards with optical illusion figures on the distraction cards enable women to focus and reduce pain and anxiety.
No study has been found in the literature examining the effects of virtual reality glasses and distraction techniques on pain, anxiety and satisfaction levels in IUD application. However, in line with the results of the study, it is thought that the IUD procedure will have a positive effect on reducing the perceived pain and anxiety of women and increase satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
It will be applied by the health personnel working in the Family Planning Counseling Polyclinic.
Study Groups
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working grup 1: Virtual Reality (VR) Group
From the preparation stage of the IUD until the IUD application process is completed, after the internet connection is provided with a smart phone for the image, by clicking on the youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video will be provided and virtual reality glasses will be provided.
Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The practice of watching nature videos with VR during the IUD application with this device is within the framework of midwifery care practices and is not a treatment option for any treatment method, tool or disease. Although the video watched with VR has no effect on medical treatment and care within the framework of midwifery care, it does not have any harmful effects on women. The participant can withdraw from this study at any time without giving any reason.
Virtual Reality (VR) Group
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.
Working Group 2: Distraction Cards Implementation Group
From the preparation stage of the IUD procedure to the completion of the IUD application process, distraction cards containing five optical illusion figures, one of the distraction techniques, will be shown to the women by the researcher . Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns are such that individuals can only see when they look carefully. During the process, the women will focus on the cards and be distracted by asking what they see on the cards by communicating face-to-face with the researcher women about the pictures and shapes they see on the cards. Thus, it is thought that the cards with optical figures on the distraction cards will enable women to focus and reduce pain and anxiety. Display of cards will take approximately 3-5 minutes
Group using distraction cards
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.
Control Group
Unlike the study group, women included in the control group will not only be shown video watching applications with virtual glasses and distraction cards. The maintenance and applications in the routine IUD application will be done exactly.
No interventions assigned to this group
Interventions
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Virtual Reality (VR) Group
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.
Group using distraction cards
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
* An introductory information form will be filled in for women in all three groups.
* While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
* Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
* The Control Group will be given routine IUD application and care.
Eligibility Criteria
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Inclusion Criteria
* IUD applied,
Exclusion Criteria
* Use of misoprostol during the procedure,
* Pre-procedure pain medication use,
* Pre-procedure anxiety medication use.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Mine Gokduman Keles
OTHER_GOV
Responsible Party
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Mine Gokduman Keles
Midwifery
Locations
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TurkishMoHKahramanmarasPH
Kahramanmaraş, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9. doi: 10.1016/j.contraception.2006.12.004. Epub 2007 Feb 16.
Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.
Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.
Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.
Hylton J, Milton S, Sima AP, Karjane NW. Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial. Womens Health Rep (New Rochelle). 2020 Aug 4;1(1):227-231. doi: 10.1089/whr.2020.0056. eCollection 2020.
Related Links
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Home/Newsroom/Fact sheets/Detail/Family planning/contraception method
WHO. New estimates show worldwide fall in unintended pregnancies since 1990-1994. 2020.
High rates of unintended pregnancies linked to gaps in family planning services: New WHO study
TNSA. Türkiye Nüfus ve Sağlık Araştırması 2018 Ne Söylüyor? 2018
Other Identifiers
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TurkishMoHKahramanmaras
Identifier Type: -
Identifier Source: org_study_id
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